Surgical articles and methods

ABSTRACT

Surgical instruments, implantable articles and surgical procedures disclosed for treating medical disorders, particularly incontinence. Improved surgical sling procedures are disclosed. Novel surgical instruments and kits for use in sling procedures are also disclosed. The present invention affords options for surgeons with concomitant advantages to the patient and the healthcare provider.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation-in-part of U.S. patentapplication Ser. No. 09/917,443 filed Jul. 27, 2001 and U.S. patentapplication Ser. No. 09/917,562 filed Jul. 27, 2001 and claims prioritythereto and of U.S. Provisional Application Serial No. 60/263,472, filedJan. 23, 2001; and U.S. Provisional Application Serial No. 60/269,829,filed Feb. 20, 2001, and U.S. Provisional Application Serial No.60/281,350, filed Apr. 4, 2001; and U.S. Provisional Application SerialNo. 60/295,068, filed Jun. 1, 2001, and U.S. Provisional Application No.60/306,915, filed Jul. 20, 2001; all of whose contents are fullyincorporated herein by reference.

BACKGROUND

[0002] Urinary incontinence is a significant health concern worldwide.Incontinence may occur when the pelvic floor weakens. There are fivebasic types of incontinence: stress incontinence, urge incontinence,mixed incontinence, overflow incontinence and functional incontinence.There are a large number of surgical interventions and procedures foraddressing incontinence.

[0003] Some surgeons are slow to adopt promising new surgical techniquesfor treating incontinence for a variety of reasons. Some are untrainedor lack experience with the new procedure. Others are simply unwillingto try new instrumentation that seems unfamiliar.

[0004] Surgical centers and hospitals have an inventory of surgicalinstruments commonly used in surgery. Surgeons are trained with thesestock surgical instruments at an early stage and become familiar withthem. In the urology field, needles, suture passers and ligaturecarriers are commonly available and surgeons often develop significantexperience and comfort with procedures that utilize them. Examples ofsuch surgical instruments included Stamey needles, Raz needles, andPereyra needles. See Stamey, Endoscopic Suspension of the VesicalNeckfor Urinary Incontinence in Females, Ann. Surgery, pp. 465-471,October 1980; and Pereyra, A Simplified Surgical Procedure for theCorrection of Stress Incontinence in Women, West. J. Surg., Obstetrics &Gynecology, pp. 243-246, July-August 1959. Some surgeons may reject anew technique simply because the instrumentation associated with thetechnique is unfamiliar.

[0005] A variety of surgical procedure options are currently availableto treat incontinence. Depending on age, medical condition, and personalpreference, surgical procedures can be used to completely restorecontinence. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling procedure.

[0006] A sling procedure is a surgical method involving the placement ofa sling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Descriptions of different slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

[0007] Sling procedures differ in the type of material used for thesling, the method of anchoring the sling material in the body and howthe sling material is inserted in the body. The time required for asurgical procedure varies, but is preferably as short as possible. Thisfactor is frequently reported in urology and gynecology literature. SeeAtherton M. J., et al., A Comparison of Bladder Neck Movement andElevation After Tension-free Vaginal Tape and Colposuspension, BritishJournal of Obstetrics and Gynaecology, November 2000, Vol. 17, p.1366-1370, Nilsson et al, The Tension-free Vaginal Tape Procedure isSuccessful in the Majority of Women with Indications for SurgicalTreatment of Urinary Stress Incontinence, British Journal of Obstetricsand Gynaecology, April 2001, Vol. 108, P. 414-419; and Ulmsten et al.,An Ambulatory Surgical Procedure Under Local Anesthesia For Treatment ofFemale Urinary Incontinence, Int. Urogynecol. J. (1996), v. 7, pps.81-86.

[0008] Although serious complications associated with sling proceduresare infrequent, they do occur. Complications include urethralobstruction, development of de novo urge incontinence, hemorrhage,prolonged urinary retention, infection, and damage to surrounding tissueand sling erosion.

[0009] The Tension-free Vaginal Tape (TVT) procedure (available fromEthicon, of N.J.) utilizes a Prolene™ nonabsorbable, polypropylene mesh.The mesh is a substantially flat, rectangular knitted article. The meshincludes a plurality of holes that are sized to allow tissue ingrowth tohelp avoid infection. A plastic sheath surrounds the mesh and is used toinsert the mesh. During the sling procedure, incisions are made in theabdominal (i.e. suprapubic) area and in the vaginal wall. Two curved,relatively large (5 mm or larger) needle-like elements are eachconnected to an end of the vaginal sling mesh. A sling-free, sharp tipend of one of the needle-like elements is initially pushed through thevaginal incision and into the paraurethral space. Using a handleattached to the needle, the needle is angulated laterally (for example,to the right) to perforate the endopelvic fascia, guided through theretropubic space and passed through the abdominal incision. The handleis disconnected and the needle is then withdrawn through the abdominalwall, thereby threading a portion of the sling through the tissue of thepatient. The handle is then connected to the other needle and thetechnique is repeated on the contralateral side, so that the mesh islooped beneath the bladder neck or urethra. The sling is positioned toprovide appropriate support to the bladder neck or urethra. At the endof the procedure, the sling ends are cut at the abdominal wall, thesheath is removed and all incisions are closed.

[0010] Complications associated with the TVT procedure and other knownsling procedures include injury to blood vessels of the pelvic sidewalland abdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. Further, a separate cystoscopyprocedure is usually required in order to confirm bladder integrity orrecognize a bladder perforation after each insertion of the needle-likeelement. One serious disadvantage of the TVT procedure, particularly forsurgeons unfamiliar with the surgical method, is the lack of informationconcerning the precise location of the needle tip relative to adjacentpelvic anatomy. A cadaver study indicated that the TVT needle is placedin close proximity to sensitive tissue such as superficial epigastricvessels, inferior epigastric vessels, the external iliac vessel and theobturator. See, Walters, Mark D., Percutaneous Suburethral Slings: Stateof the Art, presented at the conference of the American UrogynecologicSociety, Chicago (October 2001).

[0011] If the TVT needle tip is allowed to accidentally pass across thesurface of any blood vessel, lymphatic duct, nerve, nerve bundle ororgan, serious complications can anrse. These shortcomings, attempts toaddress these shortcomings and other problems associated with the TVTprocedure are disclosed in PCT publication nos. PCT WO 00/74613 and PCTWO 00/74594.

[0012] Additional problems are associated with the TVT and other slingprocedures. Removal and reuse of the handle of the TVT product is acumbersome, time consuming process, requiring the surgeon to manuallyrotate the handle until the handle is unscrewed from the needle. Reusingthe handle presents a contamination risk, particularly if the handle andscrew threads are not properly cleaned and sterilized after use on thepatient.

BRIEF SUMMARY

[0013] The present invention includes surgical instruments andimplantable articles for urological applications, particularlyincontinence surgical procedures.

[0014] The present invention is also directed to surgical kits for usein surgical procedures for treating incontinence, and improved surgicalprocedures for treating incontinence. The present invention can affordincreased convenience for surgeons with the attendant advantages for thepatient. The present invention can also exploit existing surgeontraining and preferences to contribute to better surgical outcomes.Surgical procedures utilizing the present invention have the capacity tobe shorter with concomitant advantages enjoyed by patients and thehealthcare system.

[0015] In one aspect, the present invention comprises a surgical kit orassembly of surgical instruments for treating incontinence comprising animplantable material (e.g. a sling ), at least one of a first type ofneedle, and at least one of a second type of needle. The first type ofneedle is different than the second type of needle. For example, oneneedle could be straight and the other curved, or one needle may belarger or longer than the other needle or shaped differently. A varietyof different types of needles are described herein. Providing differenttypes of needles can afford the surgeon options that are unavailablewith existing surgical kits.

[0016] The needles in the kit need not serve the same purpose. Forexample, one needle may comprise a relatively small profile (e.g. lessthan about 3.5 mm diameter in cross section) guide needle, and the otherneedle may comprise a larger sling transport needle. The guide needlemay be initially inserted suprapubically (e.g. through an abdominalincision) and then guided through a vaginal incision. The larger slingtransport needle can then be associated with the guide needle (e.g. withan optional adapter or dilator) and then guided upward through the bodyof a patient (first through the vaginal incision and then through thesuprapubic incision) by the guide needle.

[0017] In another aspect, the invention comprises a kit with a firsttype of sling material, a second type of sling material, and at leastone needle for inserting a sling material. The sling materials cancomprise synthetic or non-synthetic sling materials. In one embodiment,the sling materials can be both synthetic materials, but different typesof synthetic materials (e.g. a polypropylene mesh material and asilicone coated material). There are also many different types ofnon-synthetic materials contemplated herein. Optionally, instead ofhaving a non-synthetic sling material that has short term shelf liferelative to the rest of the elements in the kit, the kit may include anaccessory to afford construction of a sling from two differentmaterials. This enables the surgeon to customize a hybrid or compositesling from different materials (e.g. from different packages) to exploitthe different properties of the materials and to coordinate them withthe intended physiological environment.

[0018] Another kit according to the present invention includes animplantable material (e.g. a sling), a needle for inserting the sling,and a first and second type of handle for use in the surgical procedure.A variety of different types of handles are contemplated herein.

[0019] The present invention also includes articles useful in urologicalsurgical procedures. The present invention includes an adaptercomprising a body portion having first and second opposite end portions.The first end portion has surfaces for associating the article with aneedle. The second end portion has a sling associator for associatingthe article with a sling. The sling associator can comprise a universaladapter for connecting a surgical needle with different types of slingmaterials (e.g. synthetic or non-synthetic). The adapter allows thesurgeon to select one of the many options of sling materials availableso that the remaining components of the surgical kit may be utilized toimplant any sling material.

[0020] The present invention also includes a needle converter for usewith a sling assembly having an adapter or dilator. The adapter ordilator has surfaces for associating with a first type of needle (e.g. aspecialized needle in a kit). The needle converter comprises a first endportion having surfaces that are sized and shaped to engagecomplementary surfaces in the passageway of the dilator to associate theneedle converter with the dilator. The needle converter has a second endportion that is generally opposite the first end portion. The second endportion has a means for attaching the needle converter to a second typeof needle that is different than the first type of needle. The needleconverter allows the dilator of a sling assembly to be attached with aneedle that is commonly used in surgical procedures for treatingurological disorders (e.g. a Stamey needle). Thus, the needle converterallows a surgeon to connect a sling assembly with a preferred, standardneedle.

[0021] The present invention also includes novel slings and slingassemblies. The slings may be conveniently implanted without the use ofbone anchors. A sling according to the present invention comprises asynthetic surgical mesh (e.g. polypropylene) having first and secondends and a plurality of holes that are sized and shaped to afford tissueingrowth. The assembly includes a removable synthetic insertion sheathsituated about the surgical mesh. At least one suture is operativelyassociated with the surgical mesh and extends beyond the first end ofthe surgical mesh. At least one other suture is operatively associatedwith the surgical mesh and extends beyond the second end of the surgicalmesh. The sutures are adapted to be associated with a surgical needle.For example, the sutures may be tied to a needle that has a hole in itor placed in a suture passageway of a ligature carrier.

[0022] Another sling according to the present invention comprises asynthetic surgical mesh (e.g. polypropylene) having a plurality of holesthat are sized and shaped to afford tissue ingrowth. The assembly has aremovable synthetic insertion sheath situated about the surgical mesh.The sheath has first and second ends. At least one suture is operativelyassociated with the insertion sheath and extends beyond the first end ofthe insertion sheath. At least one other suture is operativelyassociated with the insertion sheath and extends beyond the second endof the insertion sheath. The sutures in this embodiment are also adaptedto be associated with surgical needles.

[0023] The novel slings may be used in novel surgical proceduresaccording to the present invention. The novel surgical procedurescomprise the steps of i) providing a novel sling according to thepresent invention, ii) creating at least one vaginal incision, ii)creating at least one suprapubic incision, iii) passing a leading end ofa needle initially through a suprapubic incision and then through thevaginal incision on one side of the patient's urethra, iv) passing aleading end of a needle initially through a suprapubic incision and thenthrough the vaginal incision on the other side of the patient's urethra,v) attaching the first suture to the leading end of a needle, vi)attaching the second suture to the leading end of a needle, vii)implanting the sling by moving the leading end of a needle from thevaginal incision toward a suprapubic incision, and viii) then removingthe synthetic insertion sheath.

[0024] Another surgical procedure according to the present inventionincludes the use of a plurality of needles with different purposes. Anovel surgical procedure includes the steps of i) providing a surgicalkit comprising at least one guide needle, and at least one slingtransport needle with a tip, a sling attached to the sling transportneedle, and an adapter having tip receiving surfaces for receiving thetip of the sling transport needle, ii) creating at least one vaginalincision, iii) creating at least one suprapubic incision, iv) initiallypassing the guide needle through the suprapubic incision and thenthrough the vaginal incision, v) attaching the adapter to the needle,vi) placing the tip of the sling transport needle in the tip receivingsurfaces of the adapter, and vii) guiding the sling transport needlefrom the vaginal incision to the suprapubic incision with the guideneedle to implant the sling. This procedure allow the surgeon to exploitthe control provided by the smaller guide needle to avoid sensitiveanatomical structures while retaining the benefit of the sling transportneedle.

[0025] The present invention also includes kits having the novelsurgical instruments, accessories, articles and slings described herein,and surgical procedures that utilize the novel structures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Other features and advantages of the present invention will beseen as the following description of particular embodiments progressesin conjunction with the drawings, in which:

[0027]FIG. 1 is a top view of a surgical kit according to one aspect ofthe present invention;

[0028]FIG. 1A is a top view of a surgical kit according to anotheraspect of the present invention;

[0029]FIG. 2 is a perspective view of one embodiment of sling deliverysystem of the present invention, showing the sling delivery systemdisassembled;

[0030]FIG. 2A is an enlarged perspective view of an optional connectorfor use in the kit of FIG. 2;

[0031]FIG. 2B is a perspective view of a sling constructed from twodifferent sling materials according to the present invention;

[0032]FIG. 2C is a perspective view of a sling having a sutureassociated therewith by means of a suture anchor;

[0033]FIG. 3 is a perspective view of a substantially straight needlefor optional use in a kit according to the present invention;

[0034]FIG. 4 is a perspective view of a needle with a curved portion foroptional use in a kit according to the present invention;

[0035]FIG. 5 is a side view of a needle with first and second handlesfor optional use in a kit according to the present invention;

[0036]FIG. 6 is a side view of another embodiment of needle for optionaluse in a kit according to the present invention;

[0037]FIG. 6a is an enlarged side view of a portion of FIG. 6;

[0038]FIG. 7 is a side view of another embodiment of needle for optionaluse in a kit according to the present invention;

[0039]FIG. 8 is a side view of an end portion of a needle for optionaluse in a kit according to the, present invention;

[0040]FIG. 9 is a side view of another embodiment of needle for optionaluse in a kit according to the present invention;

[0041]FIG. 9A is an enlarged view of a portion of FIG. 9;

[0042]FIG. 10 is a side view of another embodiment of needle foroptional use in a kit according to the present invention;

[0043] FIGS. 11-14 are side views of another embodiment of needle foroptional use in a kit according to the present invention, wherein

[0044]FIG. 11 shows the needle with a blunt member in an unlocked,extended position that is extended beyond a sharp surface,

[0045]FIG. 12 shows the sharp surface and blunt member as the bluntmember is initially deflected by tissue;

[0046]FIG. 13 illustrates the blunt member deflected to substantiallythe level of the sharp surface, such as when the needle encounterssignificant resistance from tissue; and

[0047]FIG. 14 shows the blunt member in a locked, extended positionafter the resistance associated with the tissue ends and a spring hasreturned the blunt member to the extended position;

[0048]FIG. 15 is a side view of a handle and several differentembodiments of needles adapted for use in the present invention;

[0049]FIG. 16 is a top view of the handle and the needles of FIG. 15;

[0050]FIG. 17 is an enlarged view of the ends of the needles shown inFIG. 16;

[0051]FIG. 18 is a perspective view of an embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention, and portions of a sling assembly or sling;

[0052]FIG. 18A is a perspective view showing another embodiment of anadapter for associating a needle with a sling according to an aspect ofthe present invention, and an end portion of a needle;

[0053]FIG. 18B is a side view of another embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention, and portions of a sling or sling assembly;

[0054]FIG. 19 includes perspective views of various optional handles foroptional use according to the present invention;

[0055]FIG. 20 is a side view of a needle with an optional strengtheninghandle for use in an aspect of the present invention;

[0056]FIG. 21 is a perspective view of another embodiment of slingdelivery system of the present invention, showing the sling deliverysystem disassembled;

[0057]FIG. 21A is a perspective view showing a sling constructed from amaterial different than the material shown in FIG. 21;

[0058]FIG. 21B is a side view of a suture anchor for use in an optionalsling according to the present invention;

[0059]FIG. 22 is a top view of a sling assembly according to an aspectof the present invention;

[0060]FIG. 22A is a top view of a sling assembly according to anotheraspect of the present invention;

[0061]FIG. 23 is a perspective view of one embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention;

[0062]FIG. 24 is a top view of the adapter of FIG. 23 shown sutured to asling assembly;

[0063]FIG. 25 is a side view of the adapter of FIG. 23 and a suturethreaded through a passageway in the adapter and through a sling anchoron a non-synthetic sling;

[0064]FIG. 26 is a sectional view of the adapter of FIG. 23;

[0065]FIG. 27 is a side view of a sling assembly, needle converter andneedle in a disassembled condition;

[0066]FIG. 27A shows the elements of FIG. 27 in an assembled condition;

[0067]FIG. 28 is a flow chart showing a process according to an aspectof the present invention;

[0068]FIG. 29 is a flow chart showing another process according toanother aspect of the present invention;

[0069]FIGS. 30 through 33 are perspective views sequentially showing theinsertion of a needle suprapubically in accordance with one aspect ofthe present invention, wherein:

[0070]FIG. 30 shows the needle just passing an abdominal incision;

[0071]FIG. 31 illustrates the needle as the surgeon seeks to identifythe tactile feel of the resistance provided in part by the posteriorportion of the pubic bone;

[0072]FIG. 32 shows the needle as it passes along the posterior surfaceof the pubic bone which may be used as an anatomical guide for a surgeonas the needle approaches a vaginal incision;

[0073]FIG. 33 illustrates the needle as it passes out of a vaginalincision;

[0074]FIG. 34 is a perspective view of a sling system attached to twoneedles according to an embodiment of the present invention;

[0075]FIG. 35 is a perspective view of a sling assembly being pulledupward by a needle in accordance with the present invention,

[0076]FIG. 36 is a perspective view of the sling according to thepresent invention after the adapters have been separated from the restof the assembly, but prior to final trimming;

[0077]FIG. 37 is a perspective view of the sling according to thepresent invention after the sheath has been removed and the sling hasbeen trimmed;

[0078]FIG. 38 is a perspective view of a small guide needle after it hasbeen inserted suprapubically, an adapter connected to the small guideneedle after the needle has been inserted suprapubically, and anotherlarge needle for implanting a sling that is inserted in an open end ofthe adapter in preparation for being guided through the patient by thesmall needle;

[0079]FIG. 39 is a perspective view of an accessory for use in a kitaccording to the present invention;

[0080]FIG. 40 is a perspective view of another needle according to thepresent invention that includes a schematic depiction of a feature ofthe needle;

[0081]FIG. 41 is a side view of another embodiment of adapter and slingmaterial according to the present invention; with the elements shown ina disassembled condition;

[0082]FIG. 42 is a side view of another embodiment of adapter and asling material according to another aspect of the present invention; and

[0083]FIG. 43 is a side view of the elements of FIG. 41 with theelements shown in an assembled condition.

DETAILED DESCRIPTION

[0084] The following description is meant to be illustrative only andnot limiting. Other embodiments of this invention will be apparent tothose of ordinary skill in the art in view of this description.

[0085] The present invention is directed to surgical instruments, andimplantable articles for treating medical disorders such as incontinenceor stress urinary incontinence (SUI) in both men and women. The presentinvention is also directed to improved surgical procedures that utilizethe surgical articles. Although the invention as disclosed hereingenerally refers to SUI, treatment of other urological disorders, suchas urge incontinence, fecal incontinence, mixed incontinence, overflowincontinence, functional incontinence, prolapse (e.g. vaginal anduterine), enteroceles (e.g. of the uterus or small bowel), rectoceles,cystoceles and other disorders are also included within the scope of thepresent invention. It is contemplated that the present invention mayalso be utilized in conjunction with concomitant procedures, such as,but not limited to, procedures for addressing cystocele, rectocele,vaginal prolapse and anatomic corrections.

[0086] In one aspect, the present invention comprises a surgical kit.FIG. 1A illustrates an example of such a kit 15. The kit 15 comprises animplantable material (e.g. a sling mesh provided as part of a slingassembly 46), at least one (preferably two) samples of a first type ofneedle 60, and at least one (preferably two) of a second type of needle60A. The first type of needle 60 is preferably different than the secondtype of needle 60A.

[0087] As used herein, the term “needle” is used generally to describe avariety of surgical instruments including suture passers, ligaturecarriers, needles and the like. Typically, the needle will have anelongate body and a pair of ends. The needle facilitates passage throughtissue, preferably from an abdominal incision to a vaginal incision or,alternatively from the vaginal incision to an abdominal incision. Asused in this application, when it is said that one needle is of adifferent type than another needle, it is meant that the needlessubstantially differ in a feature that can potentially affect a surgicalprocedure for treating a urological disorder. Features that can bedifferent according to the present invention include, but are notlimited to the size of the needles, the length of the needles, the shapeof the needles, the characteristics of an end of the needles (e.g. sharpor blunt surfaces, closed or open lumen), the capacity of the needle tooperate with a bladder perforation detector or a means for avoidingperforations of the bladder, the material of the needles, whether theneedles have the capacity to be tied to a suture, the strength of theneedles, the cross sectional size (e.g. diameter) or shape of theneedle, the presence of an integral handle, the presence of a bladderperforation detection feature, the degree that the needles aremalleable, whether the needles are reusable or only provided for use ona single patient, the capacity of the needles to be sterilized by aparticular sterilization procedure, whether the needles have surfacesthat are sized and shaped to engage complementary surfaces on anothersurgical article, the capacity of the needle to deliver a medicamentsuch as an anaesthetic, the capacity of the needle to include a lightingfeature, whether the needles have a portion that is movable relative toremaining portions of the needle, and other features.

[0088]FIG. 4 illustrates a curved needle 60. The needle 60 is preferablyarc-shaped and includes end 58 and end 62. The ends or tip of the needle60 are preferably not sharp, but may be tapered to afford easy passagethrough tissue while providing a blunt surface that avoids cuttingsensitive tissue such as the bladder or urethra. In a preferredembodiment, the length of the needle 60 is approximately within therange of 16.5 cm to 24.1 cm (6.5 inches to 9.5 inches) and has apreferred external diameter of approximately 3.175 mm (0.125 inch).Preferably, the diameter of the needle 60 is small relative to the priorart to reduce tissue trauma.

[0089] The needle 60 is preferably made of a malleable, yet durable,biocompatable surgical instrument material such as, but not limited to,stainless steel (e.g. 316 stainless steel or 17-4 stainless steel),titanium, Nitinol, polymers, plastics and other materials, includingcombinations of materials. The needle 60 should have sufficientstructural integrity to withstand the various forces (e.g. forces causedby dilator attachment, and penetration/passage of the needle 60 throughthe various tissues) without undergoing any significant structuraldeformation. Optionally, the needles 60 could be sufficiently malleableto allow a practitioner or user of the device to modify the needle 60 toa desired shape and, thereby, optimize the procedural approach.

[0090]FIG. 3 illustrates a substantially straight needle 60A. Somesurgeons prefer a curved needle to a straight needle for some urologicalprocedures. Others prefer straight needles to curved needles. Providingthe surgeon the option to use either needle from a surgical kit canincrease the convenience for the surgeon and can match the skillspossessed by a particular surgeon with the surgical instrumentationprovided in the surgical kit.

[0091]FIG. 6 illustrates a different type of curved needle 40 withintegral handle 44. The leading end portion 42 of the needle 40 includesa passageway (hole 42) for receiving a suture 6 used during the surgicalprocedure. FIGS. 7 and 8 illustrate a curved needle assembly 50 with acurved portion 53, an end 54, a movable handle 52 and a handle lock orstabilizer 51.

[0092]FIGS. 9, 9A and 10 show a different type of needle assembly 80comprising an end portion 81 with a passageway 82 for receiving a suture6. The passageway 82 for receiving a suture 6 is illustrated as a hole.Alternatively, the passageway could include a slot, slit or other shapefor receiving and securely grasping the suture 6.

[0093] The needle assembly 80 includes shaft 87. The end portion 81 andpassageway 82 are placeable within the sheath 87. Preferably the endportion 81 is blunt and free of any sharp surfaces. The needle 80 alsoincludes a mechanism 85 that is capable of moving the blunt end portion81 between i) an extended position with the suture passageway 82extending beyond the end of the outer sheath member 87 so that thesuture passageway can conveniently receive a suture 6, and ii) aretracted position with the blunt end portion spaced closer to the endof the outer sheath member 87 than in the extended position and forsecurely holding a suture placed within suture passageway 82.Preferably, in the retracted position, the passageway 82 is completelywithin the sheath member 87 to securely hold the suture 6 to the needle80 and to resist separation of the suture 6 and needle 80. A button 88is used to conveniently move the elements between the extended andretracted positions. Preferably, a spring is utilized to bias theelements toward the retracted position.

[0094] FIGS. 11-14 illustrate another embodiment of needle 500 foroptional use in a kit according to the present invention. The needle 500includes a handle and a sheath that remain relatively stationary. Thesheath includes a relatively sharp surface 518 for cutting tissue. Theneedle 500 also includes an inner member that is movable relative to thehandle. The inner member has a blunt end 528. Preferably, the movablemember also includes a suture passageway 529. Alternatively, the innermember could include a means for snapping onto a dilator as describedmore fully below.

[0095]FIG. 11 shows the needle 500 with a blunt member 528 in anunlocked, extended position that is extended beyond sharp surface 518.In this position, the blunt member 528 protects tissue from the sharpsurface 518 but the blunt member 528 is free to deflect inwardly whenthe needle is pressed against tough tissue (e.g. abdominal fascia). FIG.12 shows the sharp surface 518 and blunt member 528 as the blunt member528 is initially deflected by tissue.

[0096]FIG. 13 illustrates the blunt member 528 deflected tosubstantially the level of the sharp surface 518, such as when theneedle encounters significant resistance from tissue. In this condition,the sharp surface may now be exploited to cut through the tough tissueto avoid the sudden needle lurch associated with a blunt ended, priorart needle. FIG. 14 shows the blunt member 528 in a locked, extendedposition after the resistance associated with the tissue ends and spring510 has returned the blunt member 528 to the extended position.

[0097] Preferably, the needle 500 has a locking means for locking theblunt end portion 528 in the extended position to avoid injuring tissueonce the needle passes through the tough tissue. The locking meanspreferably comprises a locking leaf spring 502. One end of the leafspring 502 is preferably attached to the handle and the other end of theleaf spring 502 is movable between a locking position (FIG. 14) and arelease position (FIGS. 11-13).

[0098] The inner movable member with blunt end 528 includes a springshoulder 509, and extension arm 530 with leaf spring cam surface 537 andblocking surface 532. When the needle 500 is initially pressed againstthe tissue to be cut, the leaf spring cam surface 537 cams the end ofthe leaf spring 502 off of a retaining lip 520 (described in more detailbelow). The blocking surface 532 is adapted to engage the end of thelocking leaf spring 502 to lock the movable member in the extendedposition. Spring 510 biases the inner member toward the extendedposition. A floating spring attachment member is operatively associatedwith one end of the spring 510 and the other end engages spring shoulder509 of the inner movable member.

[0099] The needle 500 also preferably includes a release mechanism forreleasing the inner member with blunt end 528 from the locked position.The release mechanism includes a slidable button 525 assembly with aleaf spring retaining lip 520. The leaf spring retaining lip 520 issized and shaped to retain the leaf spring in the release position shownin FIG. 11. The release mechanism also includes a deflection surfaceOust adjacent retaining lip 520) to move the leaf spring from the lockedposition (FIG. 14) to the release position (FIG. 11) when the button 525is pressed.

[0100]FIGS. 15 through 17 illustrate additional examples of differenttypes of needles for use in a kit according to the present invention.Needle 202 includes two substantially straight portions situated at apredetermined angle. The needle 202 has two substantially disc shapedintegral handles, and a diamond-shaped, substantially flat end portion.The end portion includes a passageway. Needle 204 has two substantiallystraight portions at a predetermined angle that is different than theangle of needle 202. Needle 204 is also longer than needle 202 and has adifferent shaped end portion. Needle 206 has a straight and a curvedportion. Needle 206 includes a substantially flat end portion with apassageway 208. A handle 200 with a set screw may be attached to theneedle 206 (e.g. at complementary surface 209).

[0101] Needles 202, 204 and 206 are sized and shaped to be suitable foruse in surgical procedures. The needles are particularly useful fortreating urological disorders. Preferably, the needles are constructedfrom a strong biocompatible material such as stainless steel. They maybe reusable and can be sterilized by steam sterilization procedures,including flash sterilization procedures commonly located close to thesurgical location.

[0102] The different sizes and shapes of the needles provide a surgeonwith the option to use a different needle depending upon the needs of aparticular surgical procedure (e.g. size of the patient, previoussurgical procedures, scarring, , concomitant procedures, condition ofthe patient, and the anatomy of the patient, etc.).

[0103] In another aspect of the present invention, the different typesof needles need not serve the same purpose in a surgical procedure, butcould serve a different purpose. FIG. 38 illustrates a surgical guideneedle 602 (e.g. with a diameter of about 4 mm, or less, preferablyabout 3 mm) and a relatively larger sling transport needle 604 (e.g.with a diameter of 5 mm). Preferably, the sling transport member has asling assembly 610 (e.g. a sling mesh and insertion sheath) attachedthereto.

[0104] The guide needle 602 serves a different purpose than the surgicaltransport needle 604. The surgical guide needle 602 is preferably smalland has a blunt tip. The blunt tip is initially inserted through anabdominal or suprapubic incision 400 and then through a vaginal incision404. Inserting a small, blunt needle in this fashion provides thesurgeon with addition control in maneuvering through the anatomy of apatent and in avoiding sensitive tissue.

[0105] A surgical kit according to an aspect of the present inventionmay include an adapter 54 on the end of needle 602. The sling transportneedle 604 may optionally include a sharp tip. The adapter receives thetip of the needle 604. Pushing upward on the sling transport needle 604with one hand while steering the tip of the needle 604 by holding guideneedle 602 with the other hand is believed to provide better controlover insertion of a prior art large needle that is initially insertedthrough the vaginal incision 404 and then through the suprapubicincision.

[0106] Alternatively, the adapter can include surfaces for firmlyengaging and attaching to needle 604. Those surfaces can includemechanical interlocking structures, grasping structures or interlockingstructures. Optionally, a biocompatible adhesive may be used to adherethe tip of sling transport needle 604 to the adapter.

[0107]FIG. 40 illustrates a needle 60 with a bladder perforationdetector 121. A variety of means may be used as the bladder perforationdetector. The needle perforation detector can include a ph sensor fordetermining whether the ph encountered by the needle is outsideanticipated limits. For example, if the bladder has been perforated,fluid associated with such a perforation is likely to encounter the end58 of the needle and change the ph encountered by the needle. The changein ph can be used to signal that the bladder has been perforated.

[0108] The bladder perforation detector 121 preferably signals animpending bladder perforation prior to its occurrence so that itprevents bladder perforations. For example, an object may be placed inthe bladder 14 of the patient. The needle 60 and object can havecomplementary light source and detection means (e.g. a photoelectricsensor) for avoiding bladder perforations by the end 58 of the needle60. For example, the object can include a light source and a lightemitter. The needle 60 can include a light detector tuned to receivelight emitted from the object. Preferably, the object emits lightthrough the bladder 14 so that the needle 60 detects the light prior toperforating the bladder 14.

[0109] Alternatively, needle 60 may be associated with a light sourceand can emit light. In this embodiment, the object placed in the bladderincludes a photosensitive detector/receptor and can be associated withan alarm and controller. The controller can set a threshold of lightintensity detected. Above that threshold, an alarm may be used to warn asurgeon that the needle is in proximity to the bladder and that abladder perforation may be impending. Optionally, the bladder may befilled with a photoconductive medium to enhance bladder perforationdetection.

[0110] In another embodiment, the needle can have a resistance orcapacitance detector capable of detecting the change in resistanceencountered after the bladder is perforated. In another embodiment, anobject can be placed in the bladder through the urethra. The needle caninclude a proximity sensor for detecting the proximity of the needle tothe object. This type of needle can be constructed to be operativelyassociated with an alarm mechanism (e.g. audible, visual or tactile)that informs the surgeon that the needle is in proximity to the objectthat is placed in the bladder. Such a device is believed to avoidbladder perforations as, upon sensing the alarm, the surgeon may changethe path of the needle to a path that is away from a close proximity tothe bladder. Alternatively, the proximity of the needle and an object inthe bladder can close a circuit and actuate an alarm. The alarm may beaudible, visual or tactile to the user by an integral part of the needleor a separate device integrated into the system.

[0111] In another aspect of the present invention, a needle mayoptionally include the capacity to deliver a medicament (e.g.anesthesia) during the surgical procedure. For example, the needle maybe hollow with an open end. The needle may have a connector forassociating with a medicament reservoir and delivery mechanism (e.g. asyringe). As another alternative, the needle may comprise a means forconnecting to a light source to enhance visibility or for beingmonitored by a light detector placed in the bladder (e.g. to avoidbladder perforations).

[0112] Referring to FIG. 1, in another aspect the present inventioncomprises a surgical kit 11 comprising a first type of sling material(e.g. as part of the sling assembly 46), a second type of sling material10, and at least one needle (e.g. 60). As used herein, the terms “sling”or “article” or “mesh” or the phrases “implantable material” or“implantable article” or “sling mesh” (or combinations thereof) are usedgenerally to describe a variety of materials including synthetic andnon-synthetic materials. Typically, the implantable article will beelongate and substantially flat. It can be used as a hammock, sling,strip or support member. As used in this application, when it is saidthat one sling material is of a different type than another slingmaterial, it is meant that the materials substantially differ in afeature that can potentially affect a surgical procedure for treating aurological disorder. Features that can be different according to thepresent invention include, but are not limited to the ability of thesling to avoid infections or tissue erosion, the shelf life of theproduct, the type of material, the shape of the material, the presenceof a sling tensioning member (e.g. as disclosed in U.S. patentapplication Ser. No. 09/917,562, filed Jul. 27, 2001), the present of asling adjustment feature as described in U.S. Pat. Appl. Attorney DocketNo. AMS-018 filed Oct. 30, 2001 which claims priority to U.S.Provisional Application No. 60/237,075 filed Oct. 3, 2001, slingmaterial treatment, the porosity of the sling material, the shape of thesling material, the sling length, the strength of the material, theelastic property of the material, the potential for tissue ingrowth, thebiocompatibility of the material, and the presence or absence of aninsertion sheath.

[0113] While the slings are preferably rectangular for treating SUI infemales, other shapes are also contemplated. Depending on the treatmentaddressed (e.g. to provide hammock support for the bladder or bladderneck, or to address a rectocele, enterocele or prolapse) the slings maybe any of a wide variety of shapes. As an example, the sling may be ofthe general shape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).

[0114] Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia and fascia lata. Somesurgeons believe that non-synthetic materials are i) more consistentfrom lot to lot in terms of material characteristics, as opposed to somesynthetic slings whose characteristics may be believed to vary, ii) lesslikely to cause tissue erosion or are less likely to elicit an adversereaction from the patient's foreign body response mechanism as the bodyis less likely to recognize a non-synthetic material as a foreignmaterial, and iii) are less likely to be rejected by the body long term.

[0115] Suitably synthetic materials for a sling include polymerics, andplastics and any combination of such materials may also be used in a kitof the present invention. Commercial examples of such materials includeMarlex™, Prolene™, and Vaskutek™. Other examples of suitable materialsinclude those disclosed in U.S. patent application Ser. No. 09/939,098filed Aug. 24, 2001 (the entire contents of which are hereinincorporated by reference). Specific examples of synthetic slingmaterials include, but are not limited to polypropylene, polyethylene,nylon, PLLA and PGA. For example, some surgeons prefer syntheticmaterials because they believe such materials: i) are stronger and/ormore durable than many non-synthetic materials (e.g. less likely toexperience suture detachment failure), ii) have different elasticproperties, iii) are more likely to afford desirable tissue ingrowth,iv) can be readily and effectively incorporated with desirable featuressuch as antimicrobial agents, v) many non-synthetic sling materials aredifficult to acquire, and vi) present no issues of cross contaminationbetween species.

[0116] The sling material may be resorbable, absorbable ornon-absorbable. Optionally portions may be absorbable and other portionsmay be non-absorbable.

[0117] In one aspect of the invention, the sling may comprise a meshmaterial. The mesh material comprises one or more woven, knitted orinter-linked filaments or fibers that form multiple fiber junctionsthroughout the mesh. The fiber junctions may be formed via weaving,knitting, braiding, bonding, ultrasonic welding or other junctionforming techniques, including combinations thereof. In addition, thesize of the resultant openings or pores of the mesh may be sufficient toallow tissue in-growth and fixation within surrounding tissue. As anexample, not intended to be limiting, the holes may comprise polygonalshaped holes with diagonals of 0.132 inches and 0.076 inches. Holes muchsmaller than this are not preferred as they may facilitate bacterialcolonization.

[0118] The quantity and type of fiber junctions, fiber weave, pattern,and material type influence various sling properties or characteristics.Non-mesh sling configurations are also included within the scope of theinvention. As another example, not intended to be limiting, the mesh maybe woven polypropylene monofilament, knitted with a warp tricot. Thestitch count may be 27.5 courses/inch (+or −2 courses ) and 13wales/inch (+or −2 wales). The thickness of this example is 0.024inches.

[0119] In another embodiment the sling material may have one or moresubstances associated therewith through a process such as coating.Examples of appropriate substances include, without limitation, drugs,hormones, antibiotics, antimicrobial substances, dyes, siliconeelastomers, polyurethanes, radiopaque filaments or substances,anti-bacterial substances, chemicals or agents, including anycombinations thereof. The substances may be used to enhance treatmenteffects, reduce potential sling rejection by the body, reduce thechances of tissue erosion, enhance visualization, indicate proper slingorientation, resist infection or other effects. For example, the slingmay be coated by the process described in U.S. Pat. Nos. 5,624,704;5,756,145; 5,853,745; 5,902,283 and 6,162,487 (the entire contents ofwhich are hereby incorporated by reference).

[0120]FIG. 2 illustrates a sling assembly comprising sling 42 and sheath44 that are made of biocompatible materials having sufficient strengthand structural integrity to withstand the various forces exerted uponthese components during an implant procedure and/or followingimplantation within a patient.

[0121] Preferably, the overall dimensions of the sling assembly 46,including insertion sheath 44 and sling 42 are sufficient to extend froman abdominal incision, to an undersurface of the urethra and back toanother abdominal incision with additional size to account for theimprecision associated with the range of human anatomy sizes. In apreferred embodiment, the sheath length of the assembly of the presentinvention is approximately within the range of 52.0 cm to 58;5 cm (20.5inches to 23.0 inches), sheath width is approximately within the rangeof 1.0 cm to 1.63 cm (0.482 inch to 0.642 inch) and sheath materialthickness is approximately within the range of 0.127 mm to 0.203 mm(0.005 inch to 0.008 inch), respectively. The associated sling 42 has alength, width and thickness approximately within the range of 40 cm to51 cm (15.7 inches to 20.1 inches), 1.0 cm to 1.2 cm (0.394 inch to0.472 inch) and 0.508 mm to 0.711 mm (0.020 inch to 0.028 inch),respectively.

[0122] The sling 42 of the present invention can be implanted withoutthe need for bone screws. Upon implantation, a portion of the sling 42is passed and/or woven through various layers of abdominal/pelvictissue.

[0123] The sling 42 is designed to remain within the body of a patientas an implant for a predetermined therapeutically effective amount oftime. The sling may be non-absorbable, absorbable or resorbable,including any combinations of these material properties, depending onthe desired treatment. The general characteristics of the sling materialand design should be such as to withstand the various forces exertedupon it during implantation (for example, frictional forces associatedwith tissue resistance) and after implantation (for example, increasedabdominal or bladder pressure caused by a stress event).

[0124] The precise, final location of the sling 42 will depend on avariety of factors including the particular surgical procedure(s)performed, and any preconditions of the patient such as scar tissue orprevious surgeries. For example, it may be preferred to place the sling42 in close proximity to, but not in contact with, a mid portion of theurethra to treat incontinence.

[0125] In another aspect, the present invention includes an element thataffords construction of a hybrid sling from different types of slingmaterials. FIG. 2 shows a sling constructed from a synthetic material42. FIG. 2B illustrates a sling constructed from a synthetic material 42and a non-synthetic material 10. FIG. 2C shows a sling assemblyconstructed from a non-synthetic material 10. The connector 8 shown inFIG. 2A may be used to connect one type of sling material 10 to anothertype of sling material 42 or to connect a sling with a needle. Anysuitable biocompatible structure may be used as the connector 8. Forexample, one or more of the connectors described in U.S. patentapplication Ser. No. 09/749,301, filed Dec. 27, 2000, entitled“Apparatus and Methods For Enhancing the Functional Longevity and ForFacilitating the Implantation of Medical Devices” (the entire contentsincorporated herein by reference) may be used.

[0126] Referring to FIG. 2, the connector 8 may be used to attach a loop48 of sheath 44 to a dilator 54 (described more fully below) or theconnector 8 may be used to operatively associate a suture 6 with thesling assembly 46. The suture 6 may then be used to attach the slingassembly 46 to needle 60 or another type of needle.

[0127] In use, a particular surgeon may prefer to place non-syntheticmaterial (e.g. 10) in the mid portion of the sling, believing that sucha sling is less likely to erode the urethra of a patient. That surgeonmay also desire to have synthetic materials along the end portions ofthe sling, believing that such synthetic end portions are more likely toanchor in tissue and promote tissue ingrowth. In another alternative, asurgeon may construct a silicone coated synthetic sling material in themid portion of the sling to avoid tissue erosion and a polypropylenemesh material along the end portions of the sling.

[0128] The connector 8 allows the hybrid sling to be constructed justprior to the surgical procedure so that it may be customized for aparticular surgical procedure. A customized sling can account forfactors such as pre-existing scarring, patient anatomy size and theintended use for the sling (e.g. to raise the bladder neck or to merelysupport it). It can also be constructed to be complementary toconcomitant procedures (e.g. for addressing a prolapse). The connector 8can be made of Delrin, ABS, nylon, polycarbonate, acetal,polyetherimide, polysulfone or other sterilizable materials.

[0129] Other elements may be used as a means for constructing a hybridsling from a first type of sling material and a second type of slingmaterial. For example, a biocompatible adhesive or sealant (e.g. atissue adhesive or sealant) may be used. The biocompatible adhesive maycomprise any of the adhesives, sealants and implantable materialsdisclosed or referenced in U.S. Provisional Patent Application Nos.60/302,929 filed Jul. 3, 2001, and 60/307,836 filed Jul. 25, 2001, and60/325,870 filed Sep. 28, 2001 (the entire contents of which are hereinincorporated by reference). Additional commercial examples of suchadhesives, sealants and implantable materials include Tissuebond andTissuepatch available from Tissuemed, RapiSeal from Fusion, CoStasisfrom Cohesion and FocalSeal from Focal.

[0130] According to one embodiment, the sling may include a protectivesheath 44 (see FIG. 2). The sheath 44 is used during insertion of thestrip 42. After the sling 42 is implanted, the sheath 44 is removed anddiscarded. Preferably, the protective sheath 44 is constructed of amaterial that affords visual examination of the implantable slingmaterial 42 and that affords convenient passage of the assembly 46through tissue of the patient.

[0131] In a preferred embodiment, the sheath 44 is made of polyethylene.Other materials including, without limitation, polypropylene, nylon,polyester or Teflon may also be used to construct the sheath 44. Thesheath material should be flexible and provide sufficient structuralintegrity to withstand the various forces exerted on the sheath 44throughout the sling delivery procedure. In general, the sheath 44 isconfigured to have sufficient flexibility to facilitate usermanipulation and adequate structural strength to withstand the variousforces applied to the sheath 44 during delivery and/or positioning ofthe sling assembly 46. It should also conveniently separate from thesling material 42 after the sling 42 is implanted without materiallychanging the position of the sling 42.

[0132] The sheath 44 may comprise two elongate, separable sections.Optionally, portions of the sheath 44 may detachably and telescopicallyoverlap near the middle portion of the sling. In addition to resistingsling exposure and contamination, the overlapping section may also beused as a visual indicator for the practitioner or user of the device.Additionally, orientation indicia (not shown) may be placed on theoverlapping portion to indicate proper orientation of the sling relativeto the urethra. Alternatively, other configurations of the sheath 44 arewithin the scope of the present invention. In particular, the sheath maybe unitary as opposed to telescoping with perforations, slits, holes,scores or tear lines designed to allow separation and removal of thesheath 44.

[0133] During sheath removal, the first section and the second sectionof the sheath are slid off the sling 42 by pulling each end of thesheath 44 away from the middle portion of the sling assembly 46. Removalof the sheath 44 causes separation of the overlapping sheath sections,thereby exposing the sling 42. In addition, the smooth outer surface ofthe sheath 44 provides a relatively frictionless surface to facilitatepassage of the sheath 44 through the various tissues. The relativelyfrictionless motion also avoids disturbing the position of the sling 42relative to the anatomy of the patient.

[0134] In another embodiment of the invention, the sheath 44, or aportion thereof, is associated with one or more substances includingthose substances identified with respect to sling 42. The substances maybe used to enhance sheath removal, identify twists along the sheath 44(and thereby indicate proper sling orientation), indicatecutting/separation points, indicate center-point, resist infection orprovide other desirable effects. For example, a first surface of thesheath 44 may include indicia that should lie opposite the urethra orbladder neck to ensure proper sling orientation. Thus, the indiciaprovide the practitioner/surgeon with a visual indicator to aid inproperly orienting the sling assembly 46, and ultimately the sling 42,within the patient.

[0135] In another aspect, the present invention comprises an article(e.g. 54, FIG. 2) for use in a surgical sling procedure. The article 54comprises a body portion having first end portion 56 and second endportion 52 opposite the first end portion 56. The first end portion 56has surfaces for associating the article 54 with a needle (e.g. end 58of needle 60). The second end portion 52 has sling association means forassociating the article with a sling. The sling association means maycomprise a hole 90.

[0136] Preferably, the article 54 comprises a dilator that dilates aneedle track for ease of sling introduction and positioning within thepatient. End 58 of the needle 60 is preferably keyed to allow forconvenient, secure attachment of the needle 60 relative to the dilator54. In a preferred embodiment, the key feature prevents rotation of thedilator 54 relative to the needle 60.

[0137] The kits shown in FIG. 1, 1A and 2 include two dilators. Thedilator 54 atraumatically creates and/or expands the passageway throughthe tissues for sling assembly delivery. The dilator 54 is preferablyshort relative to a needle 60 for ease of passage of the assembly and toreduce the overall amount of tissue that is deflected at one time.Preferably, the dilator is less than 2.5 inches in length, and morepreferably, it is less than one inch in length. The maximum radius of adilator 54 is preferably less than 10 mm, more preferably less than 7.5mm, even more preferably less than 5 mm. The tip of the dilator 54 ispreferably blunt, as, in preferred embodiments, the leading tip of thedilator 54 will pass through tissue that has already been pierced by aneedle 60.

[0138] The dilator 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal, Delrin®,Acrylonitrile-Butadiene-Styrene (ABS), polyethylene, nylon and anycombination of biocompatible materials.

[0139] The dilator 54 preferably includes means for associating with asurgical needle 60. In a preferred embodiment, the association meansaffords a permanent affixation between the dilator 54 and the needle 60.By “permanent affixation”, it is meant that it would be very difficultto manually separate the dilator from the needle after they have becomepermanently affixed. After implantation of the sling 42, to separate thesling 42 from the dilator 54/needle 60, the surgeon cuts an end of thesling 42 as described more fully below. The association means preferablyaffords quick and convenient attachment of the dilator 54 to the needle60 to avoid wasting time in the midst of a surgical procedure. Theattachment should also be secure to avoid separation of the needle 60and dilator 54 while the combination is passed through tissue.

[0140] As seen in FIGS. 4 and 18A, the first and second ends 58 and 62of the needle 60 may include a keying feature affording secureassociation between the needle and dilator 54 and/or sheath assembly 46.In one embodiment, the keying feature comprises a recess 130 and/orsquare-shaped portion 126. As previously described, the recess 130 andsquare-shaped portion 126 are designed for complementary engagement tothe appropriate end of a dilator 54. Alternatively, a suture 6 maysimply be tied to the recessed portion of the end of the needle 60.

[0141] The dilator 54 also includes a universal sling association means(e.g. hole 90) for associating with the surgeon's choice of sling.Optionally, the dilator 54 may be preattached to the sling 42 and/orsheath 44, particularly if the sling is a synthetic material.Alternatively, the synthetic sling 42 can be cut and removed fromdilator 54, and the dilator may be attached to a non-synthetic slingmaterial (e.g. cadaveric or autologous sling material) just prior tosling placement.

[0142] Referring to the embodiment of dilator shown in FIGS. 23-26, thedilator 54 may be approximately 3.1 cm (1.2 inches) in length. Thedilator 54 preferably includes a gentle taper 88 near its first end 56.The dilator is sized and shaped to provide atraumatic passage throughbody tissue. The taper 88 and relatively smooth outer surface of thedilator 54 facilitate atraumatic passage of the dilator 54 and attachedsling assembly 46 through the various tissues of the patient. Thepresence of the dilator 54 allows a gentle transition between thediameter of the needle, to the shape of the dilator, and finally to thesling assembly 46, as opposed to prior art assemblies, where thestructure of the sling assembly abruptly increases the profile of theneedle and thereby the size of the structure that must pass throughtissue.

[0143] Preferably, the second end 52 of the dilator 54 associates thedilator with one end of a sling 42, or sheath 44 or sling assembly 46.The sheath 44 or sling 42 is preferably attached to the dilator 54 via afirst opening or through-hole 90 located near the second end of thedilator 54. In this embodiment, the opening 90 operates as a universalsling material or assembly attachment point which can receive a varietyof materials, such as fascia, autologous materials, synthetics, biologictissues and any other similar tissues, including any combinations.

[0144]FIG. 21 illustrates a first sling 42 constructed of syntheticmaterial with a plurality of through holes and a suture 6 threadedthrough a hole in synthetic material 42 that is spaced from the end ofthe synthetic material 42. FIG. 21A shows a non-synthetic sling material3 with a suture anchor 7 attached thereto. The suture anchor 7 firmlyassociates the sling 3 with the suture 6 and resists separation of thesling 3 and the suture 6. Either sling material 3 or 42 can beconveniently associated with dilator 54 by threading suture 6 throughhole 90 and tying the suture. In this fashion the dilator/adapter 54 canuniversally connect to either a synthetic (e.g. polypropylene) mesh 42or a non-synthetic sling (e.g. cadaveric fascia 10).

[0145] In the embodiment shown in FIG. 2, the end portion 48 or 50 ofone end of the sheath 44 is threaded through the opening 90 of thedilator 54 and secured to the sheath 44, thereby forming a loop.Optionally, a connector 8 may be used to secure the loop. The edgeportion 48 or 50 alternatively may be fastened onto the sheath 44 viaultrasonic welding, bonding, melting, suturing, sealing or otherattachment techniques. Further, as shown in FIG. 23, the end 52 of thedilator 54 preferably includes a cut-away section 94 to provide room toreceive sling assembly material to reduce the overall profile of thesling assembly experienced by tissue during sling passage. Therefore,when the sheath is attached to the cut-away section, the additionalsheath material is not apt to significantly increase the relativethickness, diameter or profile of the dilator 54.

[0146] As shown in FIGS. 24 and 25, one or more sutures 6 may bethreaded through hole 90 and used to connect a sling to the dilator.This gives the surgeon the option to associate the dilator with aparticular sling material just prior to implantation. Optionally, asuture anchor article 8D (FIG. 24) may be used to enhance the attachmentof the suture 6 to the sling material, particularly if the slingmaterial is sensitive to suture pull through (e.g. such as somecadaveric fascia).

[0147] Alternatively, for dilators 54 manufactured via moldingtechniques, the end of the sheath 44 may be encased within and securedto the second end 52 of the dilator 54 during the molding process. Inyet another embodiment, the end of the sheath 44 may be fixedly attachedwithin a longitudinal slot located near the first end 52 of the dilator44 using an adhesive, ultrasonic welding or other attachment techniques.

[0148] Referring to FIGS. 23-26, the first end 56 of the dilator 54includes a second opening or through-hole or lumen 96 that extendssubstantially internally along the longitudinal axis of the dilator 54.The hole 96 preferably extends the length of the dilator 54.

[0149] The lumen 96 has an internal diameter generally configured forconvenient attachment to a needle 60 or similar sling-delivery device.In one embodiment, the internal diameter of the second opening 96 of thedilator 54 is approximately within the range of 0.239 cm to 0.318 cm(0.094 inch to 0.125 inch). A shoulder 98 located on the surface 100 ofthe second opening 96 of the dilator 54 and a complementary matingrecess located on the surface of the first end of the needle 60 securelyand permanently attach or lock the dilator 54 and needle 60 together.Once the needle 60 is inserted into the dilator 54, they are preferablynot separated thereafter. After the sling 42 is implanted, the connectedneedle 60 and dilator 54 are removed from the sling by cutting an end ofthe sling as described in greater detail below. Preferable, the needle60 and dilator 54 are discarded after the surgical procedure.

[0150] One or more longitudinal slots 102 located on the outer surfaceof the dilator 54 and in communication with the second opening 96 allowthe wall of the dilator 54 to expand in a radially outward directionwhen the first end of the needle 60 is inserted into the second opening96 of the dilator 54. When the shoulder 98 of the dilator 54 passes therecess of the needle 60, the wall of the dilator 54 collapses around theneedle 60 as the shoulder 98 seats into the recess, thereby securing thedilator 54 on the needle 60 and blocking separation of the dilator 54and needle 60.

[0151] Although the invention has been described in terms of a shoulder98 and mating recess, alternative dilator-needle attachment mechanismssuch as bumps, grooves, slots, wedges, detents and other mechanisms arealso included within the scope of the claimed invention. The dilator 54preferably includes one or more relief ports 104 to facilitateconvenient needle connection. The relief ports 104 may be formed at theends of the longitudinal slots 102 or at various high-resistancelocations along the dilator 54. The relief ports 104 decrease therigidity or resistance of radially outward expansion of the dilator walland, reduce the amount of force required to insert or securely attachthe needle 60 to the dilator 54. In yet another embodiment, superficialbands or rings, arcshaped slots, superficial grooves or other mechanismsmay provide improved expansion or attachment characteristics.

[0152] A portion of the dilator 54 includes a taper 88 having adecreasing profile toward the second end 56 of the dilator 54. The taper88 preferably gently cams tissue out of the path of the sling assembly46 as the sling assembly is inserted in the body. The taper 88 is alsosized and shaped to reduce the amount of friction or resistance as thedevice is drawn through the tissues of the patient. The amount of forcerequired to manipulate the device through the tissues is therebyreduced. This in turn provides the user of the assembly with additionalcontrol over device insertion and maneuverability through tissue andwithin the patient. In addition to tapered profiles, other dilatorprofiles such as conical, flared, frusto-conical, pyramid-shaped,elliptical or other applicable profiles may also be used. Overall, theprofile of the dilator 54 is preferably configured to provide easydilation of the tissue to accommodate smooth passage of the sling42/sling assembly 46 and subsequent collapse of the surrounding tissueto securely anchor the sling 42 into the tissue (after sheath removal).

[0153] In other embodiments of the invention, shown in FIGS. 18 and 18A,a dilator 54A or 54B includes a sling fastening snap mechanism 106 or106′ on one end of the dilator. The embodiment disclosed in FIG. 18Aincludes a keyed/locking mechanism on its other end. Referring to FIG.18, the end of the dilator 54 a includes a slot or slot-shaped opening110 configured for convenient insertion of one end of a sling 42 (suchas one made from non-synthetic tissue) or sling assembly 46 (e.g. ofsynthetic materials) either at the surgical site (e.g. by the operatingroom nurse or surgeon) or other location (such as manufacturinglocation). Additional shapes for the dilator opening 110 include,without limitation, oval, circular, square, rectangular and othershapes. The slot-shaped opening 110 is located along a portion of thelongitudinal axis of the dilator 54A.

[0154] Referring to FIG. 18A, snap-like element 112′ is located on anouter surface near the first end of the dilator 54B. The snap-likeelement 112′ includes a barb or spike 114 that fits within an opening116 situated near the first end of the dilator 54B. The opening 116 forthe barb 114, preferably configured perpendicular to the slot-shapedopening 110′, is sized and shaped to match or mate with the barb 114 ofthe snap-like element 112′. When the barb 114 is fully seated within theopening 116 of the dilator 54B, the tip 118 of the barb 114 extends intothe slot-shaped opening 110′ of the dilator 54B. A first ridge 120 and asecond ridge 122 located along the length of the barb 114 further secureand/or fasten the barb 114 within the opening 116 of the dilator 54B.Other fastening configurations including, but not limited to, bumps,shoulders, tabs, detents, tongue in grooves, snaps and any combinationsof fastening means may also be used with the present invention.

[0155] During use, one end of the sling (e.g. 10 or 42, in FIG. 1),sheath 44 or sling assembly 46 is inserted into the slot 110′ of thedilator 54B. With the end of the sling 42/sling assembly 46 properlypositioned within the slot 110′, the barb 114 of the snap-like element112′ is inserted into the opening 116 of the dilator 54B. The barb 114is fully seated within the opening 116 when both ridges 120, 122 passthrough the opening 116 of the dilator 54B. This causes the tip 118 ofthe barb 114 to bear down on or penetrate a portion of the sling42/sling assembly 46 extending within the slot 110′ of the dilator 54B,thereby securely fastening the sling 42/sling assembly 46 to the dilator54B.

[0156] A keyed/locking mechanism 108 is located near the second end 56Bof the dilator 54B. As shown in FIG. 18A, a square-shaped opening 124extends along a portion of the longitudinal axis near the second end 56Bof the dilator 54B. The shape of the dilator opening 124 matches thesquare-shaped perimeter of the keying-segment 126 located near the firstend 58 of the needle 60 and allows keyed-rotation of the dilator 54B atninety-degree intervals. Other appropriate shapes for the dilatoropening 124 may also be used provided that the shape of the opening 124complements the corresponding keying-segment shape located near thefirst end 58 of the needle 60. When the first end 58 of the needle 60 ispositioned within the dilator 54B, the square-shaped opening 124 of thedilator 54B together with the keying-segment 126 of the needle 60prevents axial rotation of the dilator 54B relative to the needle 60and, thus, twisting of the sling 42/sling assembly 46. This optionalfeature provides the practitioner or user of the assembly with controland maneuverability of the assembly before and during the insertionprocedure.

[0157] The dilator 54B also includes a locking mechanism 128. Referringto FIG. 18A, the locking mechanism 128 comprises one or moretension-loaded ribs located within the longitudinal opening of thedilator 54B. The configuration of the ribs generally matches andcorresponds to a complementary recess 130 located near the first end 58of the needle 60. Thus, the first end 58 of the needle 60 is insertedthrough the longitudinal opening 124 of the dilator 54B until the ribsof the dilator 54B seat within the recess 130 of the needle 60. Thedilator 54B is securely attached or locked onto the needle 60 when thedilator ribs are fully seated within the needle recess 130.

[0158] Referring to FIG. 18B, in an alternate embodiment of theinvention, the sheath 44 (or sling 42 or 10 or assembly 46) is attachedto the dilator 54C via a locking (or compression) collet 132 and adapterconnector 134. The compression collet 132 comprises a ring-shapedportion 136 having one or more barbed snap tongs 138. The complementaryadapter 134 comprises a cylindrical element 140 having a first end 142and a second end 144. The internal profile near the first end 144 of theadapter connector 134 includes a tubular lumen or channel 146, havingone or more recesses, shoulders, grooves or similar indentations 148,surrounding an internal prong 150. The second end 144 of the adapterconnector 134 includes one or more barbed snap tongs 152, similar to thetongs 138 of the compression collet 132. In addition, the first end 52Cof the dilator 54C includes a longitudinal opening 154 having one ormore recesses, grooves, slots or related types of indentations 156configured to engage the tongs 152 of the adapter connector 134.

[0159] In use, one end of the sling (e.g. 10 or 42/sling assembly 46) ofthe present invention is configured into a tubular or appropriate shapethat enables a sufficient portion of the end of the sling 42/slingassembly 46 to be inserted through the compression collet 132. The tongs138 of the compression collet 132 are then inserted into the first end142 of the adapter connector 134, causing the tongs 138 to snap intoengagement with the adapter connector 134. The end portion of the sling42/sling assembly 46 is compressed between the tongs 138 of thecompression collet 132 and the internal prong 150 of the adapterconnector 134, thereby securely fixing the sling 42/sling assembly 46 tothe collet/adapter assembly. In a similar fashion, the tongs 152 of theadapter 134 are then inserted and snap-locked into the first end 52C ofthe dilator 54C, creating a secure fixation between the collet/adapterassembly and dilator 54C. Alternatively, a non-synthetic sling 10 couldreplace sling 42 in this embodiment of the present invention.

[0160] In another aspect of the present invention, a dilator or adapterneed not be present. Referring to FIGS. 22 and 22A, there are shownsling assemblies that may optionally be free of adapters or dilatorsaccording to additional embodiments of the present invention.

[0161]FIG. 22 illustrates a sling assembly 240 for implantation withoutthe need to use bone anchors or screws. The sling assembly 240 comprisesa synthetic surgical mesh 42A (e.g. a polypropylene surgical mesh)having a plurality of holes. The holes are preferably sized and shapedto afford tissue ingrowth. The synthetic surgical mesh is sized andshaped to be implanted during a surgical sling procedure.

[0162] Some synthetic mesh used for slings are relatively extensible.Unlike cadaveric fascia and other non-synthetic materials which tend tobe relatively slippery, an extensible sling mesh may be difficult tothread through tissue alone. Also, even if such slings could be insertedalone, some synthetic slings could be damaged during insertion, or coulddamage tissue. A removable synthetic insertion sheath 44A (e.g.polyethylene) is situated about the surgical mesh to assist in insertingthe sling mesh 42A.

[0163] The insertion sheath has first and second ends. In the embodimentshown in FIG. 22, at least one suture 6A is associated with theinsertion sheath 44A and extends beyond the first end of the insertionsheath 44A a length sufficient to afford attachment of the slingassembly to a needle. At least one other suture 6A is associated withthe insertion sheath 44 and extends beyond the second end of theinsertion sheath 44A a length sufficient to afford association of thesling assembly with a needle. Sutures 6A may be associated with sheath44A via knotting, suture anchor, tying, weaving, bonding, ultrasonicwelding or other attachment techniques, including combinations thereof,to prevent suture 6A detachment during and/or following slingimplantation. The sling 42A may optionally be associated with the sheath44A through such techniques.

[0164] The suture 6A can be attached to the needle by a multitude ofapproaches, such as being tied, knotted, or placed in a suturepassageway and retracted into the needle as described above. Forexample, the straight needle shown in FIGS. 9, 9A and 10 could be usedto implant the sling assembly 240. In use, the needle 80 is insertedsuprapubically and emerges from the body through a vaginal incision. Thebutton 88 can then be extended to expose the suture accept hole 82 andthe suture 6A can be passed through hole 82 and tied. The tied suturecould then be retracted within the sheath 87 by manipulating button 88.The needle 80 could then be pulled up through the body to implant thesling 240. Alternatively, a stock ligature carrier could be used insteadof needle 80.

[0165] Optionally, the suture 6A could be tied to a dilator or othercomponent of a needle assembly as shown in FIG. 34. Preferably, theinsertion sheath 44A defines an interior portion that includes thesurgical mesh, and an exterior portion, and the sutures 6A that extendbeyond the first and second ends of the insertion sheath 44A arecompletely situated on the exterior portion of the sheath. Alsopreferably, the insertion sheath 44A is securely attached to the sling42A, by a means such as ultrasonic welding, suturing or adhesive. Atensioning member 66 may optionally be provided.

[0166]FIG. 22A illustrates another embodiment of a sling assembly 250for use in an incontinence procedure. The sling assembly 250 isparticularly suitable for implantation without bone anchors and need notinclude a dilator or adapter. The sling assembly comprises a syntheticsurgical mesh 42D having first and second ends and a plurality of holesthat are sized and shaped to afford tissue ingrowth. The syntheticsurgical mesh 42D is preferably sized and shaped to be implanted duringa surgical sling procedure designed to treat incontinence in females. Itmay be sized and shaped to be placed mid-urethra in a tension freefashion to treat SUI. It may be long enough to extend from the patient'sabdominal fascia to the patient's urethra and back again or it may beshorter and utilize sutures 252 for anchoring in the abdominal fascia.

[0167] The sling assembly 250 includes a removable synthetic insertionsheath 44D situated about the surgical mesh 42D. At least one suture 252is associated with the surgical mesh 42D and extends beyond the firstend of the surgical mesh 42D. Preferably the suture 252 has a lengthsufficient to afford attachment of the sling mesh 42D to a needle.Another suture 252 is operatively associated with the surgical mesh andextends beyond the second end of the surgical mesh a length sufficientto afford attachment of the mesh to a needle. Sutures 252 may beoperatively associated with the mesh 42D in a variety of fashions (e.g.by tying, knotting, weaving, adhering, or welding). Alternatively, asuture anchor or pledget may be used to anchor the sutures 252 to themesh 42D.

[0168] Preferably, the insertion sheath 44D defines an interior portionthat includes the surgical mesh 42D, and an exterior portion. Suture 252preferably extends beyond the first end of the surgical mesh and extendsfrom the interior portion of the sheath 44D to an exterior portion ofthe sheath 44D.

[0169] Optionally, sutures 6D may be tied to the end of the sheath 44D.Preferably, sutures 6D are provided in a different color than sutures252. Alternatively, sutures 6D can be omitted and sutures 252 can betied to external portions of the sheath 44D.

[0170] The sutures 252 may optionally be anchored to tissue in the body(e.g. the abdominal rectus fascia) to help secure the sling. In thisembodiment, it is preferred that the sutures 252 are of a differentcolor than sutures 6D.

[0171] Referring now to FIGS. 1 and 19, there is shown another aspect ofthe present invention. In this embodiment, the present inventioncomprises a surgical kit for treating incontinence. The kit comprises animplantable material (e.g. 10), and a needle 60. The needle 60 hassurfaces for engaging a handle. The kit also includes at least one of afirst type of handle 64 having surfaces for attaching the handle to theneedle 60, and at least one of a second type of handle (e.g. see FIG.19) having surfaces for attaching the handle to the needle 60.

[0172] As used in this application, when it is said that one handle is adifferent type than another handle, it is meant that the handlessubstantially differ in a feature that can potentially affect a surgicalprocedure for treating a urological disorder. Features that can bedifferent according to the present invention include the size of thehandles, the shape of the handles, the materials used to construct thehandles, the presence, absence or location of finger indents, whetherthe handle is movable, whether the handles are repositionable, whetherthe handles are releasable, whether the handle can be indexed between aplurality of positions, and the location of operable elements. Thehandles may have any of the structure and features described in U.S.patent application Ser. No. 09/917,443 filed Jul. 27, 2001 (the entirecontents of which are herein incorporated by reference).

[0173]FIG. 19 illustrates a plurality of different types of handles.Handle 22 comprises a slim, elongate structure with a button near theproximal end. Handles 31, 35, 37 and 39 have an operable member (e.g.button) near the distal end of the handle. Handle 31 is rounded, whilehandles 33, 35, 37 and 39 are elongate. The handles may be movablerelative to a needle (e.g. slidable or rotatable), repositionable on aneedle (e.g. it may be indexed between different positions) and/orreplaceable on a needle (e.g. moved from one end to the other end of theneedle).

[0174] FIGS. 15-16 show needles 202 and 204 with integral handles. FIG.5 illustrates a first handle 64B and a second handle 64′ that may beplaced on the same needle 60B.

[0175]FIG. 20 illustrates a handle 172 that may be attached to a needle60. The handle 172 includes a strengthening portion 174 designed tostrengthen the needle 174. The handle 172 optionally includes releasableattachment means 177 for releasably attaching the handle 172 to theneedle 60. The handle 172 is particularly useful when the needle 60includes a relatively small cross sectional area or is relativelysusceptible to bending during an anticipated procedure. A kit with thehandle 172 enables the surgeon to place the handle 172 on the needle 60to avoid bending, twisting or other deformation of the needle 60 duringthe surgical procedure.

[0176] Instead of a hole 90 in the dilator 54, another mechanism may beutilized to connect a dilator 54 to a surgical sling material, sheath orsling assembly. FIGS. 41 and 43 illustrate an adapter 541. One end ofthe adapter includes a mechanism for attaching to a needle 60. The otherend of the adapter 541 includes a means for attaching to a sling 10. Themeans for attaching to a sling includes jaws 366 movable between an openposition (FIG. 41) for receiving the sling 10 and a closed position (seeFIG. 43) for firmly holding the sling 10 and resisting separation of thesling 10 from the adapter 541.

[0177] A fastening arm 365 with securement flange may fit in a hookshaped receiving slot 364 within adapter 541. Optionally, a spring (notshown) may be utilized to bias the securement flange to the end of thehook to resist separation of the jaws 366 from the remaining portion ofthe adapter 541. When the fastening arm 364 is fully inserted in theslot 364, inner surfaces of the adapter 541 engage outer surfaces of thejaws 366 to retain the jaws 366 in the closed position and to blockmovement of the jaws toward the open position. Secure associationbetween the jaws 366 resists undesirable separation of the sling 10 andthe adapter 541 within the body of the patient.

[0178]FIG. 42 illustrates another portion of an adapter. The elementshown in FIG. 42 includes jaws 359, and threads 357 that can be screwedinto complementary threads in an adapter. The jaws 359 include apiercing member 353 that can penetrate through sling or insertion sheath44. Preferably the piercing member 359 includes an enlarged end portionthat can retain the jaws 359 in a closed position and can blockseparation of the sling material. The piercing member is a positivebarrier to separation between the jaws 359 and the sling or insertionsheath 44.

[0179] Operating theatres often stock specialized surgical needles thatare commonly used by urologists. Such needles include Stamey, Raz, andPereyra needles. FIGS. 27 and 27A illustrate a needle converter 712 thatcan exploit a surgeon's comfort in using a stock needle.

[0180]FIG. 27A shows a sling assembly comprising a sling mesh material42 and a dilator 54. An optional sheath 44 is also shown. The sheath 44is threaded through hole 90 and attached to itself (e.g. by ultrasonicwelding). The dilator 54 has an end portion (opposite the end near hole90) with a passageway. The passageway in the dilator (best seen in FIG.26) includes surfaces for receiving a first type of needle (e.g. 60).

[0181] Preferably, the surgical kit that includes needle converter 712would also include a needle 60. Needle 60 has an end portion that issized and shaped to engage complementary surfaces in the passageway ofthe dilator 54 to associate the needle with the sling assembly. However,for a variety of reasons, a particular surgeon may eschew the use of afirst type of needle (e.g. 60) and instead opt to use a commonlyavailable, standard needle (e.g. a Stamey needle 204 having a hole).Such a surgeon may utilize the needle converter 712.

[0182] The needle converter 712 includes a first end portion havingsurfaces 126D and 130D that are sized and shaped to engage complementarysurfaces in the passageway of the dilator to associate the needleconverter 712 with the dilator 54. Surfaces 126D and 130D aresubstantially the same shape as surfaces 126 and 130 of needle 60 (seeFIG. 4). The needle converter 712 has a second end portion that isopposite the first end portion. The second end portion has a means forattaching the needle converter 712 to a second type of needle (e.g.Stamey needle 204) that is different than the first type of needle 60.

[0183] The connection to the second type of needle can take a variety ofshapes. A plurality of needle converters can be supplied in the samesurgical kit. FIG. 27 shows the needle converter 712 in an unassembledcondition. The needle converter includes a leaf spring 710 with alocking pin, a locking sleeve 720 and a slot 718 for receiving the endof the second type of needle 204.

[0184] The locking pin of leaf spring 710 is preferably movable betweena needle accept position (FIG. 27) that allows the needle 204 to beinserted in the needle converter, and a needle engaged position (FIG.27A) with the locking pin firmly and securely attached to the needle204. The locking sleeve 720 is moveable between a needle accept position(FIG. 27) and a blocking position (FIG. 27A) that retains the lockingpin of leaf spring 710 in the needle engaged position. Preferably, aleading end of the locking pin of leaf spring 710 is angled to cam theleaf spring to the needle accept position when the end of needle 204 isslid into slot 718. An inherent bias of the leaf spring 710 preferablycauses the locking pin to move to the needle engaged position and fullyseat in the hole in needle 204 when the needle 204 is fully inserted inthe converter 712.

[0185]FIG. 27A shows the needle converter 712 in an assembled condition.The locking pin of the leaf spring 710 is seated in a hole in the secondtype of needle 204. The locking sleeve 720 has been slid in thedirection of the arrow in FIG. 27 to encompass the leaf spring 710 andto prevent the locking pin from moving out of engagement with the holein needle 204. Sleeve 720 is preferably blunt with rounded surfaces toresist damage to the patient while it is pulled through the body.Notably, resistance by the body while the sling assembly 42, 44 ispulled through the body will tend to urge the locking sleeve 720 towardthe blocking position to resist separation of needle 204 and needleconverter 712.

[0186] A surgical kit according to the present invention may optionallyinclude additional accessories. FIG. 39 illustrates a cystoscopy aid 12.The cystoscopy aid 12 may be inserted over a thin needle 60. Thecystoscopy aid includes one or more apertures or perforations 160, thatfunction to facilitate verification of bladder and urethra integrity,are disposed along the length of the cystoscopy aid 12. For example,during use, after the needles 60 have been inserted within the patient,the cystoscopy aid 12 may be pushed along the exterior surface of eachneedle 60. If the bladder has been punctured during needle insertioncausing urine leakage or drainage within the patient, the urine orbladder fluid will enter the apertures 160 of the cystoscopy aid 12 andflow along the surface and out from the needle 60. This allows thepractitioner to quickly and easily confirm urethra and bladderintegrity.

[0187] Other accessories may also optionally be included in a kitaccording to the present invention. For example, a surgical drapespecifically designed for urological procedures such as a slingprocedure may be included in a kit of the present invention. Such adrape is disclosed in U.S. patent application Ser. No. 09/749,254, filedDec. 27, 2001 (the entire contents incorporated herein by reference).Alternatively, an article for objectively setting tension of the device,such as those described in U.S. patent application Ser. No. 09/968,239,filed Oct. 1, 2001 (the entire contents of which are incorporated byreference) may be included in the kit.

[0188] Other accessories may also be included for convenience. Forexample, if a needle includes an optical feature, then a opticalelements may be included. If a needle includes a resistance detector,then the kit may include a means for detecting a bladder perforation dueto the change in resistance encountered by a needle due to a bladderpuncture.

[0189] The kits according to the present invention preferably include atleast two needles. Two or more needles reduce the need to reuse a needleat a different location with a patient, thereby eliminating crosscontamination issues. Additional needles, handles, dilators and otherelements may also be included for surgical convenience, for avoidance ofcontamination from one portion of the body to another, for ease ofmanufacturing or sterilization or for surgical requirements.

[0190] The individual elements of the kits of the present invention maybe packaged together, separately or in subassemblies depending on avariety of factors such as shelf life and sterilization requirements.They may be assembled at the manufacturing location or at the healthcarelocation. Any suitable sterilization procedure may be utilized tosterilize the contents of a kit. Suitable sterilization techniquesinclude, but are not limited to steam, ethylene oxide, electron beam,vapor (e.g. hydrogen peroxide or peracetic acid), or plasma procedures.

Examples of Surgical Procedures

[0191] Several methods are contemplated herein. Although the methods ofuse as disclosed herein generally relate to female incontinenceconditions and treatments/procedures, male incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention. Procedures that address problems other than incontinence(e.g. cystocele, enterocele or prolapse) are also contemplated alone orin conjunction with the present invention. Further, the term “urethra,”with respect to sling positioning, is used for brevity and readerconvenience. It should be noted that the present invention isparticularly suitable for placing a sling in a therapeutically effectiveposition. The method may be utilized to support a variety of structuresat different anatomical locations. As such, the terms “target site,”“bladder”, “urethro-vesical juncture”, “vaginal vault”, “U-V juncture”and “bladder neck” are also included within the scope of the presentinvention.

[0192] The present invention includes surgical procedures that utilizethe novel surgical instruments, articles and kits described above. Thepresent invention also includes improved surgical sling procedures.

[0193] Referring now to FIGS. 1A and 28, there is shown a firstembodiment of method according to the present invention. The methodincludes step 292 of providing a surgical kit with an implantablematerial (e.g. a sling mesh from sling assembly 46), at least one of afirst type of needle (e.g. needle with curved portion 60), and at leastone of a second type of needle (e.g. straight needle 60A).

[0194] The method also includes step 294 of selecting the first 60 orthe second 60A type of needle. Next, in step 296, a decision is made asto whether the needle is initially placed through an abdominal incisionand then through a vaginal decision (e.g. a suprapubic approach). If thesuprapubic approach is utilized, the needle is inserted in the body instep 291, a sling is then associated with a portion of the needleextending through a vaginal incision in step 293. The sling is implantedin step 295. After the sling is implanted, the incisions are closed atthe end of the procedure (step 287).

[0195] Alternatively, step 298 may decide that the needle will beinitially inserted in a vaginal incision and then passed through anabdominal incision (a suprapubic approach). If an optional removablehandle is used, in step 297, it may be desirable to initially associatethe handle with the needle and then insert the needle in step 291. If noremovable handle is used or once it is removed, the sling may then beassociated with the needle (e.g. step 289) used in the transvaginalapproach. The needle is inserted (e.g. step 283), the sling is implanted(step 281), incisions are closed and the procedure ends 288.

[0196] The present invention preferably utilizes a suprapubic approach.A suprapubic approach affords greater control over the end of a needleto avoid areas with sensitive vascular structures and the obturatornerves. Further the heightened control associated with a caudad passageis believed to avoid injury to bowel tissue.

[0197] Additional methods according to the present invention are shownin FIGS. 1, 2, 21 and 29. Referring to FIGS. 1 and 29, another methodaccording to the present invention comprises the steps providing asurgical kit 312 having a first type of sling material (e.g. a syntheticmaterial associated with sling assembly 46), a second type of slingmaterial (e.g. a different type of synthetic sling material or anon-synthetic sling 10), and a surgical instrument (e.g. needle 60) forimplanting a sling material. The method includes step 314 of selectingthe first type of sling material or the second type of sling material,step 320 of associating the sling with the needle 60, and step 322 ofimplanting the sling material with the needle 60.

[0198] The method may optionally include the steps of constructing orassembling the sling from the plurality of sling material types. Step316 decides whether a sling should be constructed or whether apre-existing sling may be used. If it is decided that a hybrid slingneed not be assembled (i.e. that synthetic sling assembly 46 could beused alone), then sutures 6 and the mechanical fastener (e.g. grommet 8)may be used to attach a sling assembly 46 to dilator 54.

[0199] Notably, non-synthetic sling materials typically include storageand sterilization requirements quite different than synthetic slings. Asa result, non-synthetic slings are preferably not packaged withsynthetic slings due to considerations such as shelf life. Referring toFIG. 2, a mechanical fastener (e.g. grommet 8) may be included in asurgical kit to enable a bulk non-synthetic sling material 14 to be cutand assembled to a synthetic sling material 42. As a result, a surgeonhas the option of constructing a hybrid sling according to an aspect ofthe present invention.

[0200] A surgeon may desire to assemble a hybrid sling for a variety ofreasons. For example, some sling materials may be believed to be lesslikely to erode sensitive tissue such as the urethra. Silicone coatedslings and non-synthetic slings may be believed to be less likely toerode the urethra than some synthetic slings. Additionally, somesynthetic slings may be more likely to encourage tissue ingrowth. As aresult, as shown in FIG. 2B, the surgeon may wish to assemble a slingwith a mid portion made of one type of sling material and anotherportion made of another type of sling material. Other factors may alsoinfluence the surgeon's decision, such as previous failure of aparticular type of sling material, the existence of scarring or otheranatomical characteristics of a patient, and the influence ofconcomitant procedures.

[0201] Referring now to FIGS. 21 and 30 through 37, a preferredembodiment of surgical procedure is disclosed. Initially, the patient isplaced under local, spinal or general anesthesia. A small transverseincision 404 is made in the anterior vaginal wall 20 of a female patientfollowed by a transurethral dissection. Two small transverse suprapubicabdominal stab incisions 400 are also made near the back of the pubicbone (e.g. each about 1 cm from the midline, or alternatively, one largeincision may be made) to allow for needle entry. Optionally, twoparaurethral dissections (incisions next to the urethra) lateral to themidline may be created to allow the surgeon's finger to meet the end 58of the needle 60 during the procedure.

[0202] A handle 64 is optionally adjusted relative to needle 60according to surgeon preference and securely associated with the end 62of the needle 60. FIG. 30 shows the end 58 of needle 60 just passing anabdominal incision 400. Preferably, after the end 58 of the needle 60passes the suprapubic abdominal incision 400, the surgeons seeks toencounter resistance associated with the posterior portion of thepatient's pubic bone 402 with the end 58 of the needle 60 tocontrollably move the end 58 of the needle toward the vaginal incision404 and to help avoid damaging structures such as the urethra andbladder of the patient. The end 58 of the needle 60 is used to identifythe location of the pubic bone 402. The surgeon exploits the resistanceprovided by the pubic bone 402 to controllably pass the end of theneedle 58. This approach is preferred as it helps keep the needle 60away from major pelvic vessels, nerves and anatomical structures such asthe urethra, bowels and bladder.

[0203]FIG. 31 illustrates the end of the needle as it just passes thesuprapubic incision. FIG. 32 illustrates the needle 60 as the surgeonexperiences the tactile feel of the resistance provided in part by theposterior portion of the pubic bone 402. FIG. 32 shows the needle 60 asit passes in proximity to the posterior surface of the pubic bone 402which continues to operate as an anatomical guide for the surgeon as theneedle end 58 approaches vaginal incision 404 (see FIG. 33).

[0204]FIG. 33 illustrates the needle as it passes out of a vaginalincision 404. Optionally, with the index finger of a hand, the surgeonmay meet the end 58 of the needle via the paraurethral dissection. Thesurgeon's finger may be delicately placed adjacent endopelvic fascia ofthe patient and used to guide the needle 60 through the relatively toughendopelvic fascia and into the vaginal incision 404. This helps thesurgeon keep away from structures such as the bladder, urethra and othersensitive tissue.

[0205] The small diameter and curvature of the needles 60 help toprovide precise passage of the needles 60 to the vaginal incision 404.In addition, this needle configuration creates a minimally invasivepathway through tissue extending between the abdominal wall and pubicspace, thereby reducing the risk of perforating the bowel and/or bloodvessels and nerves located lateral to the bladder 14.

[0206] The steps described above are repeated as needed for a secondneedle 60 on the other side of the urethra 16. Once both needles areplaced, surgeons typically perform a cystoscopy to ensure that thebladder is not punctured before implanting the sling. A cystoscopyconfirms the integrity of the bladder 14 and urethra 16 or recognizes abladder perforation. The plastic cystoscopy aid shown in FIG. 39 mayoptionally be used for this purpose. The cystoscopy aid may be usedseparately or in conjunction with cystoscopy.

[0207]FIG. 34 is a perspective view of a sling system associated withtwo needles 60. Optional adapters (e.g. dilators 54) are pushed onto theends 58 of needles 60 as shown in FIG. 34. The dilators 54 arepreferably snapped irreversibly into place for a secure connection.Next, if a synthetic sling assembly (such as the sling assembly of FIG.22) is used, the plastic sheath 44A is oriented so that the optionalcenter orientation indicia (e.g. a blue mark) is facing away from thesurgical field, toward the surgeon

[0208] After the dilators 54 are attached to the needles 60, the slingassembly 46A is properly oriented so that the sling assembly 46A is nottwisted when attached to the dilators 54. After the dilators 54 andsling assembly 46A are properly positioned, the dilators 54 are securelyattached to the sling assembly 46A by tying sutures 6 through holes 90so that none of the assembly separates as the needles 60, dilators 54and sling assembly 46A are pulled through the tissues of the patient.Alternatively, the sling assemblies 240 and 250 could be associated withdilators 54 by tying any of sutures 6A, 6D or 252 to the holes 90 ofdilators 54. Alternatively, the sling assembly 46 (FIG. 2) may include aloop 48 that is threaded through hole 90 and secured via mechanicalfastener 8. A sling assembly that includes a sheath and sling material(e.g. 42) preassembled to the dilator 54 is also within the scope of thepresent invention. Additionally, it is noted that the dilator 54 iscompletely optional and that instead, the sutures (e.g. 6, 6A, 6D or252) could be tied directly to a needle (e.g. 80 or stock ligaturecarrier) without the necessity to include the adapter/dilator 54.

[0209] Once the dilators 54 are securely attached, the needles arepulled up through the suprapubic incisions, taking care to avoid contactwith sensitive tissue. The sling is then clamped with surgical clamps(not shown). During this portion of the process, the attached dilators54 and sling assembly 46A are atraumatically pulled up through theneedle paths, advancing the sling assembly 46A adjacent to and loopedbeneath the urethra 16 or target site. A portion of each end of thesling assembly 46A extending beyond the suprapubic incisions 400 isclamped and then cut to release the needles 60 and attached dilators 54.

[0210] The sling is placed in a therapeutically effective position. Theprecise anatomical position will depend upon a variety of factorsincluding the type and degree of anatomical damage or insufficiency,whether the sling procedure is combined with other procedures and othersurgeon decisions. Typically, the sling is placed midurethra, withouttension, but in position to support the midurethra. Alternatively, thesling could be placed to support the bladder neck and/or UV junction.

[0211] Once the sling assembly 46A is carefully positioned under themidurethra or target site to provide sufficient support to the targetsite, the overlapping portion of the sheath 44A located near the centerof the sling assembly 46A and optional member 66 (i.e. tensioningfilament) may then be used to center and properly position the slingassembly 46A under the midurethra. The sheath 44A is then removed.

[0212]FIG. 35 shows the sling being tightened during the surgicalprocedure. Sling tension may be tightened by placing a device, such as aclamp, across one or both ends of the sling 42, suprapubically.Generally, the surgeon grasps the mesh and tensioning filament togetheradjacent the suprapubic incision 400 and pulls to increase the degree oftightness of the mesh. FIG. 35 shows the sling after the dilators havebeen cut off, but prior to final trimming.

[0213] After the dilators 54 are trimmed off, the plastic sheath 44A isremoved from the sling mesh 42A by pulling up on both sides of thesheath 44A, preferably one at a time. Optionally, to avoidovertightening the sling mesh 42A while removing the sheath 44A, aforceps or other blunt instrument may be placed between the sling andthe urethra.

[0214] In another embodiment of the invention, shown with reference toFIG. 38, a method includes the steps of: providing a surgical kitcomprising at least one guide needle 602 with a relatively smalldiameter (e.g. less than 4 mm), and at least one sling transport needle604 with a sharp tip, a sling 610 attached to the sling transport needle604, and an adapter (e.g. dilator 54) having tip receiving surfaces(e.g. an end of innerpassageway 96 near end of the dilator having hole90) for receiving the sharp tip of the sling transport needle 604. Forexample, the sling transport needle 604 and sling 610 may comprise a TVTneedle and sling available from Ethicon of New Jersey.

[0215] The method includes the steps of creating at least one vaginalincision 404, creating at least one suprapubic incision 400, andinitially passing the guide needle 602 through the suprapubic incision400 and then through the vaginal incision 404, and associating orattaching the adapter 54 to the needle 602 (preferably after butoptionally before passage of the needle 602 from the suprapubic incisionto the vaginal incision 404).

[0216] Needles 604 are initially passed through a vaginal incision 404and toward one of the suprapubic incisions 400. While inserting theneedles 604 initially through the vagina is not preferred, it is withinthe scope of the present invention as some surgeons may prefer thisapproach due to previous surgical training, custom or personalpreference. The method includes the step of placing the sharp tip of thesling transport needle 604 in the tip receiving surfaces of the adapter54, and then guiding the sling transport needle 604 from the vaginalincision 404 to the suprapubic incision 400 with the guide needle 602 toimplant the sling 610. Handle 620 may be connected to sling attachmentend of needle 604 for this purpose. Guiding the sharp tip of the largesling transport needle 604 in this fashion is believed to help avoidcontact between the sharp tip of needle 604 and sensitive structuressuch as obturator nerves, and vascular structures such as thesuperficial epigastric vessel, the inferior epigastric vessel, theexternal iliac artery and the obturator. Optionally the adapter withreceiving surfaces may be integrally formed in the needle 602 to avoidthe need to separately attach the adapter to the needle 602. Alsooptionally, the adapter and sling transport needle 604 may includecomplementary engagement surfaces for securely attaching the needle 602to the needle 604.

[0217] In another aspect of the present invention, a needle dilator oradapter may not be needed in a surgical procedure. For example, theprocedure may utilize a sling assembly that includes a suture extendingfrom the end of the sling assembly (e.g. a sling as described inconjunction with FIGS. 22 or 22A). The method includes the steps of: i)providing the sling, ii) creating at least one vaginal incision, ii)creating at least one suprapubic incision, iii) passing a leading end ofa needle initially through a suprapubic incision and then through thevaginal incision on one side of the patient's urethra, iv) passing aleading end of a needle initially through a suprapubic incision and thenthrough the vaginal incision on the other side of the patient's urethra,v) attaching the first suture to the leading end of a needle, vi)attaching the second suture to the leading end of a needle, vii)implanting the sling by moving the leading end of a needle from thevaginal incision toward a suprapubic incision, and viii) then removingthe synthetic insertion sheath. In one embodiment, the needle maycomprise a needle or ligature carrier (e.g. such as needle 80 shown inFIGS. 9, 9A and 10) that includes a retractable suture holder forsecurely holding the suture to the needle while the needle and slingassembly are drawn up through the body. A single needle (e.g. the sameneedle 80 used on both sides of the urethra) or two needles could beused in this embodiment of surgical procedure.

[0218] Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A surgical kit for treating incontinencecomprising: an implantable material suitable for a sling procedure, atleast one of a first type of needle suitable for a sling procedure, andat least one of a second type of needle suitable for a sling procedure,wherein the first type of needle is different than the second type ofneedle.
 2. A surgical kit according to claim 1 wherein the first type ofneedle comprises a substantially straight needle and the second type ofneedle comprises a needle with a curved portion.
 3. A surgical kitaccording to claim 1 further including a synthetic insertion sheathassociated with the implantable material to form a sling assembly.
 4. Asurgical kit according to claim 3 further including an adapter forassociating the sling assembly with a surgical needle.
 5. A surgical kitaccording to claim 4 wherein the adapter for associating the slingassembly with a surgical needle comprises a dilator.
 6. A surgical kitaccording to claim 1 wherein the first type of needle comprises a needlewith at least two handles.
 7. A surgical kit according to claim 1wherein the first type of needle includes an end portion with apassageway for receiving a suture.
 8. A surgical kit according to claim7 wherein the passageway for receiving a suture comprises a hole.
 9. Asurgical kit according to claim 1 wherein the first type of needlecomprises a movable inner member with a blunt end portion having asuture passageway and an outer sheath member with a sheath end, andmeans for moving the blunt end portion between i) an extended positionwith the suture passageway extending beyond the outer sheath member, andii) a retracted position with the blunt end portion spaced closer to theend of the outer sheath member than in the extended position.
 10. Asurgical kit according to claim 9 wherein the sheath end comprises asubstantially sharp surface for cutting tissue, and the first type ofneedle includes a means for locking the blunt end portion in theextended position.
 11. A surgical kit according to claim 1 wherein thefirst type of needle includes at least two straight portions situated ata predetermined angle.
 12. A surgical kit according to claim 1 furthercomprising a first type of handle and a second type of handle whereinthe first type of handle is different than the second type of handle.13. A surgical kit according to claim 1 wherein the first type of needleis larger than the second type of needle.
 14. A surgical kit accordingto claim 1 wherein the first type of needle includes a bladderperforation detector.
 15. A surgical kit for treating incontinencecomprising: a first type of sling material for implanting during a slingprocedure, a second type of sling material for implanting during a slingprocedure, at least one needle that is sized and shaped for inserting asling material.
 16. A surgical kit according to claim 15 wherein thefirst type of sling material is a synthetic sling material and thesecond type of sling material is a non-synthetic sling material.
 17. Asurgical kit according to claim 15 further including a universal adapterfor associating a sling material with the needle.
 18. A surgical kitaccording to claim 15 wherein the universal adapter comprises acompression collet.
 19. A surgical kit according to claim 15 furtherincluding a means for constructing a sling from the first type of slingmaterial and the second type of sling material.
 20. A sling assembly forimplantation without bone anchors, the sling assembly comprising: asynthetic surgical mesh having first and second ends and a plurality ofholes that are sized and shaped to afford tissue ingrowth, the syntheticsurgical mesh being sized and shaped to be implanted during a surgicalsling procedure, a removable synthetic insertion sheath situated aboutthe surgical mesh, at least one suture operatively associated with thesurgical mesh and extending beyond the first end of the surgical mesh alength sufficient to afford associating the mesh with a needle, and atleast one other suture operatively associated with the surgical mesh andextending beyond the second end of the surgical mesh a length sufficientto afford associating the mesh with a needle.
 21. A sling assemblyaccording to claim 20 wherein the insertion sheath defines an interiorportion that includes the surgical mesh, and an exterior portion, andthe suture extending beyond the first end of the surgical mesh extendsfrom the interior portion of the sheath to an exterior portion of thesheath.
 22. A sling assembly for implantation without bone anchors, thesling assembly comprising: a synthetic surgical mesh having a pluralityof holes that are sized and shaped to afford tissue ingrowth, thesynthetic surgical mesh being sized and shaped to be implanted during asurgical sling procedure, a removable synthetic insertion sheathsituated about the surgical mesh and having first and second ends, atleast one suture operatively associated with the insertion sheath andextending beyond the first end of the insertion sheath a lengthsufficient to afford attachment of the sling assembly to a needle, andat least one other suture operatively associated with the insertionsheath and extending beyond the second end of the insertion sheath alength sufficient to afford attachment of the sling assembly with aneedle.
 23. A sling assembly according to claim 22 wherein the insertionsheath defines an interior portion that includes the surgical mesh, andan exterior portion, and the sutures extending beyond the first andsecond ends of the insertion sheath are completely situated on theexterior portion of the sheath.
 24. An article for use in a surgicalsling procedure, the article comprising: a body portion having first andsecond opposite end portions, the first end portion having surfaces forassociating the article with a needle, and the second end portion havinga sling associator for associating the article with a sling.
 25. Anarticle according to claim 24 wherein the sling associator comprises ahole.
 26. An article according to claim 24 wherein the sling associatorincludes a slot for receiving a first or a second type of sling or slingassembly and a securement means for securing the first or the secondtype of sling or sling assembly to the article.
 27. An article accordingto claim 24, wherein the sling associator comprises jaws movable from anopen position for receiving a sling material to a closed position thatfirmly retains the sling and that resists separation of the sling fromthe article.
 28. A surgical kit assembly comprising: a sling assemblycomprising a sling mesh material and an adapter, the adapter having anend portion having a passageway, a first type of needle having first andsecond end portions, at least one of the end portions being sized andshaped to engage complementary surfaces in the passageway of the endportion of the adapter to associate the needle with the sling assembly,and a needle converter having a first end portion having surfaces thatare sized and shaped to engage complementary surfaces in the passagewayof the adapter to associate the needle converter with the adapter, theneedle converter having a second end portion, opposite the first endportion, which second end portion has a means for attaching the needleconverter to a second type of needle that is different than the firsttype of needle.
 29. A needle converter for use in a surgical slingprocedure that utilizes a dilator for use with a first type of needle,the needle converter comprising: a body portion, a first end portionhaving surfaces that are sized and shaped to engage complementarysurfaces in a passageway of a dilator to associate the needle converterwith the dilator, second end portion, opposite the first end portion,which second end portion has a means for attaching the needle converterto a second type of needle that is different than the first type ofneedle.
 30. A surgical kit assembly comprising: a first type of slingmaterial for implanting during a sling procedure, at least one needlethat is sized and shaped for inserting a sling material, and slingassembly means for affording construction of a customized sling from thefirst type of sling material and a second type of sling material.
 31. Asurgical kit according to claim 30 wherein the sling assembly meanscomprises a grommet constructed from a biocompatible material.
 32. Asurgical sling procedure comprising the steps of: providing a kitcomprising a first type of sling material for implanting during a slingprocedure, and a sling assembly means for affording construction of asling from the first type of sling material and a second type of slingmaterial, constructing a sling by selecting at least a portion of thefirst type of sling material and a second type of sling material and byassociating the selected first type of sling material with the secondtype of sling material, and implanting the constructed sling.
 33. Asurgical sling procedure according to claim 32 wherein the step ofproviding a sling assembly means comprises the step of providing amechanical fastener to attach the first type of sling material to thesecond type of sling material.
 34. A surgical sling procedure fortreating incontinence comprising the steps of: providing a surgical kithaving a first type of sling material for implanting during a slingprocedure, a second type of sling material for implanting during a slingprocedure, and a surgical instrument for implanting a sling material,selecting the first type of sling material or the second type of slingmaterial from the surgical kit, and implanting the selected slingmaterial with the surgical instrument.
 35. A surgical procedureaccording to claim 34 where in the step of providing a first type ofsling material comprises providing a first type of polymeric slingmaterial, and the step of providing a second type of sling materialcomprises the step of providing a second type of polymeric slingmaterial that is different than the first type of polymeric slingmaterial.
 36. A surgical sling procedure for treating incontinencecomprising the steps of: providing a surgical kit with an implantablematerial suitable for a sling procedure, at least one of a first type ofneedle that is sized and shaped for inserting a sling, and at least oneof a second type of needle that is sized and shaped for inserting asling, wherein the first type of needle is different than the secondtype of needle, selecting the first or the second type of needle, andimplanting the implantable material using the selected needle.
 37. Amethod of implanting a sling to treat urinary incontinence in a patientcomprising the steps of: providing a surgical kit comprising at leastone guide needle, and at least one sling transport needle with a tip, asling attached to the sling transport needle, and an adapter having tipreceiving surfaces for receiving the tip of the sling transport needle,creating at least one vaginal incision, creating at least one suprapubicincision, initially passing the guide needle through the suprapubicincision and then through the vaginal incision, attaching the adapter tothe needle, placing the tip of the sling transport needle in the tipreceiving surfaces of the adapter, and guiding the sling transportneedle from the vaginal incision to the suprapubic incision with theguide needle to implant the sling.
 38. A surgical kit for treatingincontinence comprising: at least one guide needle, at least one slingtransport needle with a tip, and a sling attached to the sling transportneedle, and an adapter having tip receiving surfaces for receiving thetip of the sling transport needle and having means for attaching to theat least one guide needle.
 39. A surgical kit according to claim 38wherein the adapter is integral with the guide needle.
 40. A method oftreating incontinence in a female patient comprising the steps of:providing a synthetic surgical mesh having first and second ends and aplurality of holes that are sized and shaped to afford tissue ingrowth,and a removable synthetic insertion sheath situated about the surgicalmesh, extending a first suture through the surgical mesh and beyond thefirst end of the surgical mesh, extending a second suture through thesurgical mesh and extending beyond the second end of the surgical mesh,creating at least one vaginal incision, creating at least one suprapubicincision, passing a leading end of a needle initially through asuprapubic incision and then through the vaginal incision on one side ofthe patient's urethra, passing a leading end of a needle initiallythrough a suprapubic incision and then through the vaginal incision onthe other side of the patient's urethra, attaching the first suture tothe leading end of a needle on one side of the patient's urethra,attaching the second suture to the leading end of a needle on the otherside of the patient's urethra, implanting the sling by moving theleading end of a needle from the vaginal incision toward a suprapubicincision, and then removing the synthetic insertion sheath.
 41. A methodof treating incontinence in a female patient comprising the steps of:providing a synthetic surgical mesh having a plurality of holes that aresized and shaped to afford tissue ingrowth, a removable syntheticinsertion sheath situated about the surgical mesh and having first andsecond ends, associating a first suture with the insertion sheath andextending the first suture beyond the first end of the insertion sheath,associated a second suture with the insertion sheath and extending thesecond suture beyond the second end of the insertion sheath, creating atleast one vaginal incision, creating at least one suprapubic incision,passing a leading end of a needle initially through a suprapubicincision and then through the vaginal incision on one side of thepatient's urethra, passing a leading end of a needle initially through asuprapubic incision and then through the vaginal incision on the otherside of the patient's urethra, attaching the first suture to a leadingend of a needle on one side of the patient's urethra, attaching thesecond suture to the leading end of a needle on the other side of thepatient's urethra, implanting the sling by moving the leading end of aneedle from the vaginal incision toward a suprapubic incision, cuttingend portions of the sling mesh and synthetic insertion sheath toseparate them from portions implanted in the patient, and removing aremaining portion of the synthetic insertion sheath from the surgicalmesh.
 42. A surgical kit for treating incontinence comprising: animplantable material suitable for a sling procedure, a needle that issized and shaped for inserting a sling, the needle having surfaces forengaging a handle, and at least one of a first type of handle havingsurfaces for attaching the handle to the needle, and at least one of asecond type of handle having surfaces for attaching the handle to theneedle, wherein the first type of needle is different than the secondtype of needle.